Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Additional Information about Patents

Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	9549909	05/03/2033			U-2858		07/24/2020
001	9549909*PED	11/03/2033
001	9603814	05/03/2033			U-2858		07/24/2020
001	9603814*PED	11/03/2033
001	9603815	05/03/2033			U-2858		07/24/2020
001	9603815*PED	11/03/2033
001	9610260	05/03/2033			U-2858		07/24/2020
001	9610260*PED	11/03/2033
001	10452815	06/29/2038			U-2859	Y	07/24/2020
001	10452815*PED	12/29/2038
001	10478441	05/03/2033			U-2860		07/24/2020
001	10478441*PED	11/03/2033
001	10478442	05/03/2033			U-2860		07/24/2020
001	10478442*PED	11/03/2033
001	10603290	08/02/2037			U-2861 U-3347		07/24/2020
001	10603290*PED	02/02/2038
001	10947183	12/20/2036	DS	DP			04/06/2021
001	10947183*PED	06/20/2037
001	11040018	08/02/2037			U-2861 U-3347		07/22/2021
001	11040018*PED	02/02/2038
001	11406606	08/02/2037			U-3406 U-3407		08/19/2022
001	11406606*PED	02/02/2038
001	11759440	08/02/2037			U-3694		10/16/2023
001	11759440*PED	02/02/2038
001	11786487	08/02/2037			U-3733		11/09/2023
001	11786487*PED	02/02/2038